System for endoscopic suturing

ABSTRACT

A system for endoscopic suturing is provided having an endoscope, such as a gastroscope, with a distal end locatable in the body of a patient and a flexible shaft extending to the distal end, a flexible accessory tube coupled to the endoscope to be movable relative to the endoscope&#39;s shaft, and a tip coupled to the shaft of the endoscope having an opening through which one end of the accessory tube is received. A tissue suturing instrument is provided having a partially flexible shaft locatable through the accessory tube, and a tissue engaging end coupled to the shaft. The tissue engaging end has a vacuum sleeve enabling suction to be selectably applied at the tissue engaging end to capture tissue through an opening in the vacuum sleeve. Two needles are provided which extend through the shaft of the suturing instrument. Each needle is separately actuated into a gap in the instrument&#39;s tip, through tissue suctioned into the opening of the vacuum sleeve and into a ferrule at each end of a loop of suture. The system further includes a suture securing instrument having a partially flexible shaft locatable through the accessory tube, and a distal end coupled to the shaft. After removal of the suturing instrument from the accessory tube, a loop of suture extends through the tissue and the accessory tube, the suture securing instrument receives the free ends of the loop of suture at its distal end through a sleeve member, and the suture securing instrument is then inserted through the accessory tube to the location of the suture in the tissue. The suture securing instrument crimps the sleeve member and cuts the free ends of the suture to secure the suture closed. The suturing instrument and suture securing instrument are passed through the accessory tube without removal of the endoscope from the patient. The endoscope provides viewing by an operator of the engaging end of the suturing instrument for selecting placement of the suture through tissue, and of the distal end of the suture securing instrument to secure the suture closed.

FIELD OF THE INVENTION

The present invention relates to a system (and method) for endoscopicsuturing, and in particular to a system for suturing through anaccessory tube coupled to a flexible endoscope, which may be placed inthe stomach through mouth and the esophagus of a patient utilizing atissue suturing instrument and a suture securing instrument. Theinvention is suitable, for example, for applying at least one suture inthe soft tissue lining of the stomach for different procedures such asgastroplasty, fundoplication, anterior gastropexy, or other proceduresrequiring suturing in the stomach, without the need for laparotomy orlaparoscopy.

BACKGROUND OF THE INVENTION

Application of sutures in the gastrointestinal tract is required forseveral different types of medical procedures, for example, transoralendoscopic valvuloplasty for gastroesophageal reflux disease,gastroplasty, fundoplication, anterior gastropexy, suturing esophagealperforations, or closure of esophageal side of tracheo-esophagealfistula. Traditionally, these procedures were performed by physicians,such as gastroenterologist or surgeons, either by laparoscopy or opensurgical techniques. Such procedures are invasive, as laparoscopyrequires small access incision(s) made in the body of the patientthrough which a laparoscope and other surgical enabling tools areprovided, while open surgical techniques are traditionally invasive andcan have complications and long patient recovery periods.

The solution to these problems is to perform these medical proceduresthrough the gastroesophageal tract via the mouth or other naturallyoccurring orifices. Already available flexible endoscopes, commonlycalled gastroscopes, can be provided through the gastroesophageal tractand enable illumination and visualization of tissue along thegastroesophageal tract on a video display for diagnostic purposes.Although gastroscopes often have a working channel to a port at thedistal end of the gastroscope through which a biopsy tool may beprovided to obtain tissue samples, they are not currently designed ortypically large enough to be capable of applying sutures in tissue.

U.S. Pat. No. 5,792,153 describes a sewing device coupled to the distalend of an endoscope, which enables suturing in the gastroesophagealtract of a patient. The sewing device has a single hollow needle mountedin the biopsy channel of the endoscope, and a wire extending through theneedle to a T-shaped tag having one end of a suture thread which extendsoutside of the patient. To apply a suture, suction is applied to aU-shaped opening of the sewing device via another channel of theendoscope to suck a layer (or fold) of tissue into the U-shaped opening,the needle in the biopsy channel is then pushed through the tissue, andthen the wire is pushed and rotated to position the tag in a chamberalong one side of the U-shaped opening. This rotates the tag into aposition which captures the tag and the suture end in this chamber, andthe needle and wire are retracted to the other side of the U-shapedopening. The endoscope and its coupled sewing device are removed fromthe patient, leaving a loop of suture through the tissue which must thenbe secured and closed. The patent also provides another sewing device atthe end of an endoscope which enables multiple stitches in tissue withthe same needle and suture thread. The sewing device of U.S. Pat. No.5,792,153 to apply a single stitch is manufactured by Laboratories BARDS.A. of Voisinsle Bretonneux, France, and described in Kadirkamanathanet al., Gastrointestinal Endoscopy, August 1996, Vol. 44, No. 2, pp.144-162.

Once the suture thread is placed through the tissue with the sewingdevice of U.S. Pat. No. 5,792,153, the suture thread must be secured andthen cut close to the tissue. One device also manufactured byLaboratories BARD S.A., and described in U.S. Pat. No. 5,755,730,provides for securing and cutting suture using an endoscope. The devicepasses through the biopsy channel of the endoscope is order to push aknot made by a physician or surgeon, which ties the ends of a loop ofsuture thread together, down to the tissue, and then a cutting membercut the ends of the suture. Since the sewing device of U.S. Pat. No.5,792,153 does not allow normal use of its biopsy channel of theendoscope upon which the sewing device is mounted, a second endoscopemust be used to secure and cut the suture through its biopsy channelusing the device described in U.S. Pat. No. 5,755,730. This results inmultiple passes of endoscopes back and forth through thegastroesophageal tract, especially if single sutures are each appliedand secured at multiple locations in tissue. To reduce possible damageto the esophageal tract and to facilitate multiple instrumentinsertions, an overtube is first placed in the esophageal tract and eachendoscope is inserted and removed through the overtube. However, theovertube may be uncomfortable to patients, and can cause complications,such as mucosal tears in the esophagus. Accordingly, it would bedesirable to provide a system for suturing which does not requiredifferent endoscopes for suture placement and suture securing, andmoreover can apply and secure multiple single sutures in tissue with thesingle insertion of a flexible endoscope, i.e., gastroscope withoutrequiring an overtube.

Other sewing devices or machines mounted on the end of an endoscope aredescribed in U.S. Pat. Nos. 5,037,021 and 4,841,888. These sewingdevices similarly utilize two channels of the endoscope, one to suctiontissue into a slot of the device and the other to advance and retract awire coupled to needle through the tissue. The needle has a suture loopat its tip such that when the needle is advanced through the slot itextends into a chamber where a hook or U-shaped member pivots to retainthe suture loop when the needle retracts. A wire is coupled to the hookand extends through the same channel where suction is provided, suchthat movement of this wire pivot the hook to capture the suture thread.Removal of the sewing device then leaves a loop of suture through thetissue.

A further sewing device is described in U.S. Pat. No. 5,080,663 and alsoutilizes an operating device having tubes in a tubular sheath, such asendoscopic means, to provide suction to a slot in the device to capturea double fold of tissue and two wires extending through such tubes. Onewire advances and retracts a needle having a tag with suture at its tipthrough tissue and the other wire controls capture of a tag at the otherside of the opening. The patent provides for applying a sensor ortransmitter in the body of a patient, such as the stomach. This sewingdevice is also described in Swaine et al., An endoscopically deliverabletissue-transfixing device for securing biosensors in thegastrointestinal tract, Gastrointestinal Endoscopy, November/December1994, Vol. 40, No. 6, pp. 730-737.

Like the sewing devices of U.S. Pat. No. 5,792,153, those described inU.S. Pat. Nos. 5,037,021 4,841,888, and 5,080,663 have the samedrawbacks as these devices are also mounted on an endoscope. Moreover,mounting on an endoscope limits the use of the endoscope for fullvisualization of tissue, as the sewing device partially obstructs theviewing area at the distal end of the endoscope. Further the use of thebiopsy or working channel of an endoscope for needle placement does notallow use of the channel for other purposes, such as obtaining a biopsy.Accordingly, it would further be desirable to provide for suturing witha flexible endoscope which allows for more complete traditional use ofthe endoscope.

SUMMARY OF THE INVENTION

Accordingly, it is the principal object of the present invention toprovide an improved system for endoscopic suturing that overcomes thedrawbacks of the prior art.

It is another object of the present invention to provide an improvedsystem for endoscopic suturing which allows single insertion of anendoscope and accessory tube assembly in the gastrointestinal tract of apatient through which multiple instruments for suturing and securingsutures can be used without removal of the endoscope between suturingand suture securing operations.

It is a further object of the present invention to provide an improvedsystem for endoscopic suturing which provides a channel to sew throughindependent of an endoscope.

Yet a further object of the present invention is to provide an improvedsystem for endoscopic suturing in which a suturing instrument separatefrom an endoscope can utilize suction to capture tissue to be sutured.

A still further object of the present invention is to provide animproved system for remote suturing in which can readily adapted todifferent types of flexible endoscopes to provide an external accessorytube through which medical or surgical instruments can pass.

A still further object of the present invention is to provide animproved system for endoscopic suturing which utilizes one or moreinstruments which each have a sufficient flexible shaft to pass throughan external flexible accessory tube attached to a flexible endoscope.

A further object of the present invention is to provide an improvedsystem for endoscopic suturing using instruments having shafts withenhanced flexibility.

And a still further object of the present invention is to provide animproved system for endoscopic suturing using flexible instruments withmechanical or hydraulic steerability.

Yet a further object of the present invention is to provide an improvedsystem for endoscopic suturing in which remote viewing with an endoscopeof suture and suture securing operations is provided in the stomachwithout hindering endoscope functionality.

Briefly described, a preferred embodiment of this system embodying theinvention includes an endoscope, such as a gastroscope, having a distalend locatable in the body of a patient, such as in the gastrointestinalor gastroesophageal tract, and a flexible shaft extending to the distalend, a flexible accessory tube coupled to the endoscope to be movablerelative to the endoscope's shaft, and an attachment tip coupled to theshaft of the endoscope having an opening through which one end of theaccessory tube is received. The accessory tube is coupled to the shaftof the endoscope with multiple tube guides enabling the accessory tubeto slide through the tube guides in response to bending of theendoscope's shaft. The accessory tube has a cannula through which aninstrument may pass in the accessory tube. The system includes a tissuesuturing instrument having a partially flexible shaft locatable throughthe accessory tube, and a tissue engaging end coupled to the shaft whichis viewable by the endoscope at its distal end when the instrument isfully inserted through the accessory tube. The tissue engaging end has avacuum sleeve enabling suction to be selectably applied at the tissueengaging end to capture tissue in a gap of a sew tip through an openingin the vacuum sleeve. Suction is applied via a vacuum connectionassembly to a channel which extends down the shaft to the sew tip. Avalve is provided to close one end of the suture carrying channel toenable such suction at the sew tip. Two needles are provided whichextends through the shaft of the suturing instrument. Each needle isseparately actuated into the gap of the sew tip through suctioned tissueto capture a ferrule having one end of a loop of suture. The systemfurther includes a suture securing instrument having a partiallyflexible shaft locatable through the accessory tube, and a distal endcoupled to the shaft which is viewable by the endoscope at its distalend when the instrument is fully inserted through the accessory tube.After removal of the suturing instrument from the accessory tube, a loopof suture extends through the tissue through the accessory tube, thesuture securing instrument receives the free ends of the loop of sutureat its distal end through a sleeve member, and the suture securinginstrument is then inserted through the accessory tube to the locationof the suture in the tissue. The suture securing instrument crimps thesleeve member and cuts the free ends of the suture to retain the sutureclosed. The endoscope enable an operator, such as a surgeon,gastroenterologist, or other skilled physician, to view the engaging endof the suturing instrument for selecting placement of the suture throughtissue, and of the distal end of the suture securing instrument tosecure the suture closed.

The suturing instrument in the system may further include a mechanismfor steering the tissue engaging end of the instrument independent ofsteerability of the flexible endoscope.

A method embodying the present invention is also provided having thesteps of: locating an endoscope, such as a gastroscope, coupled to anaccessory tube through the gastrointestinal or gastroesophageal tract ofa patient; inserting a suturing instrument through the accessory tube toplace two ends of a loop of suture through tissue of thegastrointestinal or gastroesophageal tract; removing the suturinginstrument to leave a loop of suture in the tissue having two free endsextending from the accessory tube; inserting a suture securinginstrument having a distal end with a sleeve member through which thefree ends of the suture loop are drawn to the suture in the tissue tocrimp the sleeve member and cut the free ends of the suture; andremoving the suture securing instrument from the accessory tube.

Optionally, the suturing instrument and suture securing instrument maybe used without the accessory tube when an internal working of biopsychannel is provided in the endoscope that permits the passage of theshaft of the suturing instrument and suture securing instrument,respectively.

The following description referring to the endoscope as a gastroscopefor purposes of illustration. Other types of endoscopes may be used inthe system and method.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing objects, features and advantages of the invention willbecome more apparent from a reading of the following description inconnection with the accompanying drawings, in which:

FIG. 1 is a perspective view of the system in accordance with thepresent invention for application of a suture in tissue;

FIG. 1A is a partial view of endoscope shaft of FIGS. 1 and 2 showingthe attachment of a tube guide to the endoscope while enabling theaccessory tube to be slidable through the tube guide in response toflexing of the endoscope's shaft;

FIG. 1B is an expanded view of the distal end of the system of FIG. 1;

FIG. 2 is a perspective view of the system of FIG. 1 with the sutureinstrument of the system removed;

FIG. 2A is an expanded view of the distal end of the system of FIG. 2;

FIG. 3 is a perspective view of the accessory tube, cannula, attachmenttip and tube guides of FIGS. 1 and 2;

FIG. 4 is a perspective view of the tube guide of FIG. 3;

FIG. 4A is a side view of the tube guide of FIG. 4;

FIGS. 5 and 5A are front and back perspective views, respectively, ofthe attachment tip of FIG. 3;

FIG. 6 is a perspective view of the cannula of FIG. 3;

FIG. 7 is cross-sectional view of the cannula along lines 7-7 of FIG. 6;

FIG. 8 is a perspective view of the suturing instrument of FIG. 1;

FIG. 9 is a side view of the suturing instrument of FIG. 1 in which theright cover of the housing of the instrument is removed;

FIG. 10 is an exploded view of the suturing instrument of FIG. 1 inwhich the right cover of the housing is removed;

FIG. 10A is a perspective view of the retainer member of the suturinginstrument of FIGS. 9 and 10;

FIG. 10B is a side view of the cam member of the suturing instrument ofFIGS. 9 and 10;

FIG. 11 is a partially exploded perspective view of the adapter, needlespreader, and gasket member of the suturing instrument of FIGS. 9 and10;

FIG. 11A is a cross-sectional view through lines 11A-11A of FIG. 11showing the gasket member of the suturing instrument of FIG. 11 withoutthe suture tube or needles;

FIG. 11B is an end view of the gasket member of FIG. 11 without suturetube or needles;

FIG. 12 is a cross-sectional view along lines 12-12 of the suturinginstrument of FIG. 9;

FIG. 13 is a cross-sectional view along lines 13-13 of the suturinginstrument of FIG. 9;

FIG. 14 is a cross-sectional view along lines 14-14 of the suturinginstrument of FIG. 9;

FIG. 15 is a cross-sectional view along lines 15-15 of the suturinginstrument of FIG. 9;

FIG. 16 is a cross-sectional view along lines 16-16 of the suturinginstrument of FIG. 9;

FIG. 17 is a cross-sectional view along lines 17-17 of the suturinginstrument of FIG. 9;

FIG. 17A is an exploded view of the coupler member, sew tip, and theguide member between the coupler member and sew tip, of the suturinginstrument of FIGS. 9 and 10;

FIG. 17B is a perspective view showing the connection of the couplermember, sew tip, and the guide member of FIG. 17A;

FIG. 17C is a cross-sectional view along lines 17C-17C of the FIG. 17B;

FIG. 18 is a perspective view of the vacuum connection assembly of thesuturing instrument of FIGS. 9 and 10 for application of a vacuum orpartial vacuum;

FIG. 18A is an exploded view of the vacuum connection assembly of FIG.18;

FIG. 18B is a cross-sectional view of the vacuum connection assemblyalong lines 18B-18B of FIG. 18;

FIG. 18C is a cross-sectional view along lines 18C-18C of the suturinginstrument of FIG. 9;

FIGS. 19A and 19B are perspective view of the valve seat and valve knobof the valve of the suturing instrument of FIGS. 9 and 10;

FIG. 19C is schematic diagram of an alternative valve for the suturinginstrument of FIGS. 9 and 10;

FIGS. 20A, 20B, and 20C illustrate the valve seat in response to therotation of the valve knob from an open state to a closed state to sealone end of the suture tube of the suturing instrument of FIGS. 9 and 10;

FIG. 21 is an exploded view of the distal end of the suturing instrumentof FIG. 9;

FIG. 21A is an exploded view of the distal end of the FIG. 9 showing thesleeve into which the tissue engaging end of the suturing instrument isreceived;

FIG. 21B is a side view of the tissue engaging end of the suturinginstrument with the sleeve of FIGS. 21 and 21A;

FIGS. 21C and 21D are perspective views showing assembly of the sleeveof FIGS. 21 and 21A;

FIGS. 22A-22H illustrates at the tissue engaging end of the suturinginstrument the process of applying one end of a loop of suture throughtissue with either one the two needles of the instrument;

FIG. 22I illustrates at the tissue engaging end of the suturinginstrument after both of the needles of the instrument have applied thetwo ends of the suture loop in the tissue, such that removal of theinstrument leaves the suture loop through the tissue;

FIG. 23 illustrates the operation of the tissue engaging end of thesuturing instrument in accordance with another embodiment of theinstrument without the outer sleeve of the tissue engaging end, wheresuction is not needed to capture tissue in applying a suture;

FIG. 24 is a perspective view of the suture securing instrument of thesystem in accordance with the present invention to retain close thesuture applied by the suturing instrument;

FIG. 24A is a side view of the suture securing instrument of FIG. 24 inwhich the right cover of the housing of the instrument is removed;

FIG. 24B is an exploded view of the suture securing instrument of FIG.24 in which the right cover of the housing is removed;

FIGS. 24C is a cross-sectional view through lines 24C-24C of the suturesecuring instrument of FIG. 24A.

FIGS. 24D is a cross-sectional view through lines 24D-24D of the suturesecuring instrument of FIG. 24A.

FIGS. 24E is a cross-sectional view through lines 24E-24E of the suturesecuring instrument of FIG. 24A.

FIGS. 24F is a cross-sectional view through lines 24F-24F of the suturesecuring instrument of FIG. 24A.

FIG. 24G is a cross-sectional view through lines 24G-24G of the suturesecuring instrument of FIG. 24A.

FIG. 25 is exploded view of the distal end of the suture securinginstrument of FIG. 24;

FIGS. 25A and 25B illustrate the assembly of the distal end of thesuture securing instrument of FIG. 24;

FIG. 25C is a cross-section of the distal end of the suture securinginstrument along lines 25C-25C of FIG. 25B;

FIGS. 26A-26D illustrates the use of a loading device for placement of asleeve member into the distal end of the suture securing instrument ofFIG. 24, in which FIG. 26D further illustrates a guide wire loop forloading of suture in the instrument;

FIGS. 26E-26I illustrate use of the guide wire loop of FIG. 26D to loadthe suture through the sleeve member at the distal end of the suturesecuring instrument of FIG. 24;

FIGS. 27A-27I illustrates at the distal end of the suture securinginstrument the process of fastening a sleeve member to retain thesutured tissue closed and cutting of the suture; FIGS. 28A-28M representan example of the view through the endoscope for applying of a suture bythe suturing instrument of the system of FIG. 1 and then secured inplace by a suture securing instrument of the system;

FIG. 29A is an example of the system of the present invention positionedin the gastroesophageal tract of a patient before insertion of thesuturing instrument;

FIG. 29B is an example of the system of the present invention positionedin the gastroesophageal tract of a patient showing insertion of thesuturing instrument through the accessory tube of the system;

FIG. 29C is an example of the system of the present invention positionedin the gastroesophageal tract of a patient after placement of the suturethread and removal of the suturing instrument from the accessory tube ofthe system;

FIG. 29D is an example of the system of the present invention positionedin the gastroesophageal tract of a patient showing placement of thesuture thread loop in the suture securing instrument;

FIG. 29E is an example of the system of the present invention positionedin the gastroesophageal tract of a patient showing insertion of thesuture securing instrument through the accessory tube of the system;

FIG. 29F is an example of the system of the present invention positionedin the gastroesophageal tract of a patient showing the secured sutureremaining after removal of the suture securing instrument;

FIG. 30 is a perspective view of another embodiment of the suturinginstrument in the system of FIG. 1 having enhanced flexibility;

FIG. 31 is a schematic diagram of the needle assembly for each of thetwo needles in the embodiment of the suturing instrument of FIG. 30;

FIG. 32 is an exploded view of the coupler member, sew tip, andmulti-lumen tube in the embodiment of the suturing instrument of FIG. 30in which the needles are removed;

FIG. 32A is a partial perspective view of an example of the needles ofFIG. 31 extending through one end of the multi-lumen tube of FIG. 32;

FIG. 33 is an exploded view of coupler member and sew tip of theembodiment of the suturing instrument of FIG. 30 in which themulti-lumen tube of FIG. 32 is replaced by two needle carrying tubes andone suture supply tube;

FIG. 34 is an exploded view similar to FIG. 33 showing in more detailthe needle carrying tubes of FIG. 33; FIG. 35 is a schematic diagram ofthe needle assembly of FIG. 31 extending through one end of a needlecarrying tube of FIG. 33;

FIG. 35A is a schematic diagram of alternative needle carrying tubes ofFIGS. 33-35;

FIG. 35B shown in more detail one end of the needle carrying tube ofFIG. 35A;

FIG. 36 is an exploded view of the tissue engaging end of a furtherembodiment of the suturing instrument of the system of FIG. 1 in whichthe vacuum connection assembly of the instrument is not required;

FIG. 36A is a side view of the tissue engaging end of the suturinginstrument of FIG. 36 with the attachment tip partially broken away;

FIG. 37 is a perspective view of the tissue engaging end of the suturinginstrument of the system of FIG. 1 without a sleeve to providerotational locking of the tissue engaging end in the attachment tip ofthe accessory tube;

FIG. 38 is a side view of the attachment tip of the accessory tube toprovide rotational locking with the tissue engaging end of the suturinginstrument of FIG. 37, in which the interior of the attachment tip ispartially broken away to show the slots into which the tissue engagingend can engage;

FIG. 39 is a cross-sectional view along lines 39-39 of FIG. 38;

FIGS. 40, 40A, 41, 42, 42A-42C, and 45A-45D are diagrams illustrating anoptional hydraulic steering mechanism for the tissue engaging end of thesuturing instrument of FIG. 1 using a cylinder of FIG. 42 and 42A orfolding piston of FIGS. 42B-C and 45A-45D; and

FIGS. 43, 43A, 44, and 44A are diagrams illustrating an optionalmechanical steering mechanism for the tissue engaging end of thesuturing instrument of FIG. 1.

DETAILED DESCRIPTION OF THE INVENTION

Referring to FIG. 1, a system 10 for suturing is shown including anaccessory tube 12 and an endoscope 14, referred to herein after as agastroscope, or other type of flexible endoscope having a shaft 14 acoupled to the accessory tube, and a suturing instrument 16. Thesuturing instrument 16 may be inserted in the accessory tube 12 as shownin FIG. 1, and is removable from the accessory tube 12 as shown in FIG.2. The accessory tube 12 has access tubing 18 which is sufficientlyflexible to be movable with the flexible shaft 14 a of the gastroscope.Tubing 18 is braid reinforced with a braid of stainless steel, nylon, orKevlar, to maintain the integrity of the tubing's circularcross-sectional shape and avoid kinking as the shaft 14 a of thegastroscope bends when placed through the mouth into thegastrointestinal tract of a patient. The braiding may be located betweentwo layers of tubing 18, which are integrated with the braiding duringtheir extrusion forming tubing 18. For example, the outer diameter oftubing 18 may be 0.263 inches, while the internal diameter of tubing 18may be 0.231 inches, and is such that a tissue engaging end 16 a coupledto shaft 16 b of suturing instrument 16 can pass through the tubing.Tubing 18 may be composed of pebax, polyurethane, or other flexibleplastics of medical grade. The accessory tube 12 further has a cannula20 attached to tubing 18 through which instruments, such as suturinginstrument 16, may pass. Cannula 20 is describe is more detail later inconnection with FIGS. 6 and 7. Accessory tube 12 is shown as a separatecomponent in FIG. 2.

Multiple tube guides 22 couple tubing 18 to shaft 14 a of gastroscope14. Each tube guide 22 has an opening 22 a extending through the tubeguide and a curved surface 22 b along its length which abuts the outercurved surface of shaft 14 a, as shown in FIGS. 1A. FIGS. 4 and 4A showthe tube guide 22 in more detail. Tube guides 22 may be attached toshaft 14 a by a band of tape 24 having an adhesive layer to fix the tubeguide to shaft 14 a. Other attaching means are also be used, such asglue. The diameter of opening 22 a is slightly larger than the outerdiameter of tubing 18 such that the tubing 18 is slidable throughopening 22 a to enable the accessory tube 12 to move in concert withflexing, bending, rotation, or other movements of the gastroscope 14.Tube guides 22 maintain tubing 18 substantial coaxial with shaft 14 a ofgastroscope 14. Preferably, four tube guides are provided as shown inFIGS. 1, 2, and 3, but other number of tube guides may be used.

At the distal end of accessory tube 12 is an attachment tip 26 havingtwo openings 26 a and 26 b to receive one end of tubing 18, and thedistal end 14 b of gastroscope 14, respectively. Attachment tip 26 isshown in more detail in FIG. 1B, and as a separate component in FIGS. 5and 5A. Tubing 18 is attached to attachment tip 26, such as by glue orinsert molding, while the gastroscope's distal end 14 a is held byfriction and seats in a shelf or lip 26 c (FIG. 5) which forms a stoplimiting forward movement of distal end 14 a. The attachment tip 26 maybe made of urethane or other molded plastic material. The length of theaccessory tube 12 from its cannula 20 to attachment tip 26 may be, forexample, 30 inches, but also may be of other lengths. Gastroscope 14 maybe any typical gastroscope, such as that manufactured by Olympus, Inc.,Pendax, Inc., Vision-Sciences, or Welch Allyn. For purposes ofillustration, gastroscope 14 has at its upper end 14 c a handle 27 a,two dials 27 b to steer the gastroscope, and various buttons/knobs tocontrol typical gastroscope operation. The distal end 14 b of thegastroscope has elements for imaging optics 28 a, illumination 28 b,water for cleaning imaging optics 28 c, and a biopsy or working channel28 d representing tubing in communication with a port 27 c at upper end14 c. A video display system 193 (FIG. 29B) is coupled to upper end 14a, via a cable 27 d, to allow viewing of tissue from its distal end 14 bon a display via optics 28 a. Although a gastroscope is referred toherein, any other flexible endoscope may similarly be used. FIGS. 2 and2A illustrate the accessory tube 12 and gastroscope 14 when noinstrument is located in the accessory tube.

Cannula 20 may be a typical type of cannula providing a sealable passageto tubing 18. For purposes of illustration, cannula 20 is shown in FIGS.1-3, and in more detail in FIGS. 6 and 7. Cannula 20 has a housing 20 aand a cap 20 b which is received in housing 20 a. Two seals 20 c and 20d are provided in cannula 20 along a passage 21 from an opening 21 athrough which the shaft of an instrument may pass into tubing 18. Tubing18 is received in an opening 20 f which extends into housing 20 a. Seal20 c may be a duck-bill seal as illustrated in FIG. 7. An optionalauxiliary port 20 e has a bore 20 f which opens to passage 21 throughwhich water, air, or vacuum may be provided through tubing 18. Althougha cannula with two seals is described, the cannula may alternativelyhave a single seal. Seal 20 d provides sealing about the shaft of aninstrument, while seal 20 c provides sealing when no instrument islocated in the accessory tube 12.

The assembly of the gastroscope 14 and accessory tube 12 when in thegastrointestinal or gastroesophageal tract of a patient provides thefeature of enabling instruments, such as the suturing instrument, andthe later to be described suture securing instrument, to be insertableand retractable about the distal end of the gastroscope, withoutrequiring removal of the gastroscope. Further, normal functionality ofthe gastroscope in viewing is provided without any partial obstructionor loss of use of the working channel 28 d. An illustration of thesystem 10 in a patient's body is shown in FIGS. 29A-29F.

Referring to FIGS. 8-10, the suturing instrument 16 of system 10 isshown. Suturing instrument 16 represents the SEW-RIGHT® SR•5™manufactured by LaserSurge, Inc. of Rochester, N.Y., which has beenmodified to have a longer and partially flexible shaft 16 b extendingfrom a housing 30, and means for selectably establishing suction tocapture tissue at its tissue engaging end 16 a. The tissue engaging end16 a and needles thereto may be similar to that shown in U.S. Pat. Nos.5,431,666, 5,766,183, or European Patent No. EP 0669101, filed Feb. 23,1995 and granted Oct. 14, 1998, which are herein incorporated byreference The shaft 16 b represents an assembly of components 51-62described below. Shaft 16 b is rigid along a first section 32 when itextends from opening 31 in housing 30 and then is flexible along asecond section 33 until coupling to the tissue engaging end 16 a.

The housing 30 has a body shaped like a pistol having a handle portion30 a, and may be made of a two-piece construction of molded plastic. Apair of needles 34 and 35 extends from housing 30 through the shaft 16 binto the tissue engaging end 16 a. Each needle 34 and 35 has anon-tissue engaging end in the housing having a spherical member 34 aand 35 a, such as a ball or bearing, respectively, attached thereto.Both needles 34 and 35 and spherical members 34 a and 35 a may be a madeof metal, such as surgical stainless steel. The spherical member 34 aand 35 a may have a bore into which the non-tissue engaging ends of theneedles 34 and 35, respectively, extend and joined thereto, such as bywelding or brazing.

The suturing instrument 16 includes an actuator member 36 representing alever having two pins 36 a extending into holes in the sides of housing30 upon which the actuator member is pivotally mounted in the housing.Actuator member 36 has a portion which extends through an opening 30 b(FIG. 10) in housing 30 to enable pivotal movement about pin 36 a. Anextension spring 38 is provided which hooks at one end in a notch 36 bof actuator member 36 and is wound at the other end around a pin 40located in holes in the sides of housing 30, such that the actuatormember 36 is spring biased to retain actuator member 36 normally in aforward position, as shown for example in FIG. 9. The body of housing 30has a front portion 31 (FIG. 10) providing a stop that limits thepivotal movement of the actuator member 36. A notch 36 c is provided inthe actuator member 36 which is shaped to received one of thenon-engaging ends of needles 34 or 35, i.e., spherical members 34 a or35 a, to be driven forward by an operator pulling actuator member 36 topivot actuator member 36 towards handle portion 30 a. Two grooves 36 d(FIG. 10) are provided by three fingers 36 e into which the needle 34 or35 near the spherical members 34 a or 35 a, respectively, may lie.

A retainer member 42 is fixed in housing 30 by two flanges 42 a aboveactuator member 36. As best shown in FIG. 10A, the retainer member 42has a chamber 42 b having a lower opening 42 c to chamber 42 b and twogrooves 42 d formed by fingers 42 e which allow the spherical members 34a or 35 a of needles 34 or 35, respectively, to be received in chamber42 b to restrict movement of the needle when held therein. The lowersurface 42 f of retainer member 42 is curved and faces correspondinglycurved upper surface 36 f of actuator member 36, such that the actuatormember 36 is slidable along lower surface 42 f responsive to theoperator pulling the actuator member.

To select which of the needles 34 and 35 is to be driven by actuatormember 36, the instrument 16 has a needle selection mechanism having aselector lever (or arm) 44 which is rotationally coupled with a cammember 46. The cam member 46 and selector lever 44 is supported by anadapter 48 in housing 30. Adapter 48 is mounted in housing 30 by twoflanges 48 a. The selector lever 44 is pivotally mounted by a pin 48 cextending upwards from adapter 48 at a hole 44 a through the lever.Selector lever 44 extends through an opening 30 c in housing 30 and hasa downwardly protruding member 44 b which is received in a notch 46 a ofcam member 46 to rotate cam member 46 in a pocket 48 b in the adapter 48as the selector lever 44 is moved left or right. The cam member 46 mayhave a tapered surface 46 b to facilitate its rotation in pocket 48 band two tapered apertures 46 c through which needles 34 and 35respectively extend, as shown in FIG. 10B. To select needle 34 to bedriven, the selector 44 is moved right which rotates the cam member 46to position needle 34 down and needle 35 up, such that end 34 a islocated in notch 36 c and end 35 a is located in chamber 42 b ofretainer member 42. To select needle 35 to be driven, the selector 44 ismoved left which rotates the cam member 46 to position needle 34 up andneedle 35 down, such that end 35 a is located in notch 36 c and end 34 ais located in chamber 42 b of retainer member 42.

The needle selector 44 may further have another downwardly protrudingmember 44 c which rides in a slot 42 g on the upper surface of retainermember 42. The slot 42 g is contoured to have angled lower regions oneither side of a raised region into which member 44 c can be located toreleasably lock to retain the position of lever 44 left or right.

The adapter 48 has a bore extending there through in which a needlespreader 50 is located. Needle spreader 50 has two channels 50 b and 50c into which needles 34 and 35 are respectively located to increase thedistance between the needles 34 and 35 as they extend toward cam member46, such that the needles are properly aligned to apertures 46 b in thecam member.

A suture routing tube 47 is provided for suture thread in housing 30.Suture routing tube 47 has one end received in a valve assembly 19,described later below, at the bottom of handle 30 a of housing 30 andthen extends through notches 30 d (FIG. 10) along the interior of theleft side of housing 30, and a groove 50 a along needle spreader 50(FIGS. 10 and 11). A cross-section through needle spreader 50 andadapter 48 is shown in FIG. 12. The other end of the suture routing tube47 is then mounted in a hole 51 a through gasket member 51. Gasketmember 51 further has two holes 51 b and 51 c through which needles 34and 35, respectively extend. A cross-section of shaft 16 b throughgasket member 51 is shown in FIG. 13. The gasket member 51 may be madeof medical grade rubber, such as Santoprene.

A longitudinal guide member 53 is provided multiple tracks along itslength, including two needle tracks 53 a and 53 b for needles 34 and 35,respectively, and a suture track 53 c for suture thread extending fromopening 51 a of gasket member 51. A cross-sectional view of shaft 16 bthrough guide member 53 is shown in FIG. 14. The guide member 53 may bemade of extruded flexible material, such as Tecoflex®. A rigid tube 52is provided which is D-shaped at one end 52 a is registered into acorresponding shaped opening in adapter 48, and a threaded nut 54 havingan opening which extends over mounting tube 52 and screws onto the endof the adapter 48 to secure tube 52 to housing 30. With the gasketmember 51 loaded first into rigid tube 53, guide member 53 extends fromthe gasket member 51 through the rigid tube. In this manner, tracks 53a, 53 b, and 53 c each form a channel with the interior surface of rigidtube 52. Rigid tube 52 may be made of stainless steel, or other rigidmaterial, and has for example, rigid tube 53 has an outside diameter of0.205 inches. FIG. 11 shows the gasket member 51 prior to beingpositioned in abutment to needle spreader 50 and in end 52 a of rigidtube 52. For inside rigid tube 52, gasket member 51 has a ring 51 dwhich frictionally engages the interior surface of tube 52, hole 51 a ofthe gasket member is of a diameter such that the suture tube 47 tightlyfits therein and provides a seal around suture tube 47. The suture tube47 may be held in place in hole 51 a by friction, but adhesive may alsobe used. FIGS. 11A and 11B show gasket member 51 in more detail. Holes51 b and 51 c are of a larger diameter than the needle, except for asmall section of holes 51 b and 51 c where the diameter reduces to formflaps 51 e and 51 f, respectively of gasket material which seal aroundneedles 34 and 35, respectively. This enables movement of the needlesback and forth while maintaining a seal about each needle. One featureof the gasket member 51 is that it enables sealing the shaft 16 b, suchthat negative pressure, i.e., suction, may be selectively applied downthe shaft via a vacuum connection assembly 64, as described later below.

At the other end 52 b of rigid tube 52, a coupler member 56 is mountedin which two tabs 56 a are received in two tracks 53 d along twoopposing sides of guide member 53. Coupler member 56 joins thenon-flexible section 32 of the shaft 16 b provided by rigid tube 52 withthe flexible section 33 of the shaft 16 b (FIG. 8). Coupler member 56may be composed of stainless steel. A cross-section of shaft 16 bthrough coupler member 56 is shown in FIG. 15. The coupler member has atrack 56 b for suture, tracks 56 c and 56 d for needles 34 and 35,respectively, and a central hole 56 e. On the side of the coupler member56 opposite guide member 53 is another longitudinal guide member 58which extends through the flexible section of shaft 16 b to the tissueengaging end 16 a. Guide member 58, like guide member 53, is of anextruded flexible material, such as Tecoflex®. Guide member 58 hasmultiple tracks, including two needle tracks 58 a and 58 b for needles34 and 35, respectively, and a suture track 58 c for suture threadextending from track 56 b of coupler member 56. A cross-sectional viewof shaft 16 b through guide member 58 is shown in FIG. 16. Two tabs 56 fextend from the coupler member 56 into tracks 58 d of guide member 58. Awire 60 extends from the tissue engaging end 16 a through a central hole58 e of guide member 58 and the central hole 56 e of coupler member 56,and then partly into a center hole 53 e (FIG. 14) extending into guidemember 53. The wire 60 extends partly through central hole 53 e tofacilitate registration of guide member 53 to coupler member 56 andguide member 58. The wire 60 is located in a central hole whichextending into a sew tip 98 at the tissue engaging end 16 a and attachedthereto, such as by welding or brazing, passed through guide member 58via hole 58 e, and then extended through and in coupler member 56, whereit is attached to the coupler member, via a tube coupler 57, such as bywelding or brazing. This assembly is described in more detail below inconnection with FIG. 17C. With the rigid tube 52, gasket 51, guidemembers 53 and 58 and central wire 60 in place, a plastic shrink wraplayer or tubing 62 is installed along shaft 16 b from the vacuumconnection assembly 64 until the tissue engaging end 16 a, and shrunk inresponse to applied heat onto exposed surfaces of shaft 16 b. Aboutguide member 58, tracks 58 a, 58 b, and 58 c each form a channel withthe interior surface of shrink wrap layer 62.

The connection of coupler member 56, guide member 58 and a sew tip 98 ofthe tissue engaging end 16 a is best illustrated in FIGS. 17A and 17B inwhich tabs 56 f of coupler member 56 are received in tracks 58 d at oneend of guide member 58, and tabs 100 from sew tip 98 are received intracks 58 d at the other end of guide member 58. Wire 60 extends throughcoupler member 56, guide member 58 into a hole 98 h extends into therear section 98 i of the sew tip 98 (FIG. 21B). The guide member 58 withthe shrink wrap enables the flexible section 33 of shaft 16 b to bendand flex while maintaining the channels extending there through, whilethe wire 60 provide longitudinal support to the flexible section as itis attached to non-flexible section 30 at coupler member and the sewtip. Further, needles 34 and 35 are sufficiently flexible to bendwithout deformation within guide member 58. In order to translaterotational motion from the non-flexible section, tabs 56 a and 56 f ofcoupler member-are registered into tracks 53 d and 58 d of guide members53 and 58, respectively, and then tracks 58 d of guide member 58 intotabs 100 of sew tip 98. Thus rotation occurring at the non-flexiblesection, such as by rotation of housing 30, is translated to tissueengaging end 16 a.

FIG. 17C shows the attachment of wire 60, coupler member 56, andflexible section 33 of instrument 16 in more detail, such that possibledamage to guide members from the heat of welding or brazing of metalcomponents is avoided. The coupler member 56 has a recessed circularopening 56 h to central hole 56 e at the end 56 g of coupler member 56into which one end 57 a of a wire coupler tube 57 is located. Wirecoupler 57 represents a metal tube having an outer diameter sized to bereceived in recessed opening 56 h and an inner diameter sized to receivethere through wire 60. Prior to attachment of coupler member 56 to guidemember 53, wire coupler 57 is first attached to coupler member 56, suchas by welding or brazing, about recessed opening 56 h prior to theassembly of the flexible section 33 components, i.e., sew tip 98, andguide member 58, to coupler member 56. Next, wire 60, which has not yetbeen passed through coupler member 56, is attached, such as by weldingor brazing, into hole 98 h (FIG. 21B) of sew tip 98. Wire 60 is thenslid through central hole 58 e of guide member 58 and hole 56 e ofcoupler member 56, and the sew tip 98 at two tabs 100 frictionallyengages into two tracks 58 d of guide member 58 at one end of guidemember 58. At the other end of guide member 58, tabs 56 e of couplermember 56 frictionally engages into tracks 58 d. With the coupler member56 integrated with guide member 58, wire 60 is attached at end 57 b ofwire coupler 57, such as by welding or brazing, which integrates theassembly of coupler member 56 with flexible section 33 of the instrument16, as shown in FIG. 17B. Thereafter, the coupler member 56 at its tabs56 f frictionally engages into tracks 53 d of guide member 53, such thatwire 60 partly extends into central hole 53 e of guide member 53. Theguide member 53 and coupler member 56 of the assembly are received intothe rigid tube 52, such that guide member 53 abuts gasket 51, andcoupler member is attached to rigid tube by mechanical fastening byforming small dents in the metal of the tube 52 with a press intorecessed four pockets 56 i (FIG. 17A), i.e., two on each side of thecoupler member 56.

Referring to FIGS. 18 and 18A-C, a vacuum connection assembly 64 forsuturing instrument 16 is shown. Vacuum connection assembly 64 includesa front housing member 66 which has a circular opening 66 a to aninterior chamber 66 b, and a rear housing member 68 having a circularopening 68 a extending there through. Rear housing member 68 has a firstextension toward housing 30 providing a shaft 68 e having an annularflange 68 b and a second extension toward front housing member 66providing a threaded shaft 68 c. Shaft 68 c is screwed in a threadedopening 66 c (FIG. 18B) to chamber 66 b of front housing member 66,whereby surface 68 d of the rear housing member tightly fits (mates)along surface 68 d of the front housing member 66. Circular opening 66 ais coaxial with circular opening 68 a through their respective housingmembers. A rubber O-ring 71 is provided in an annular groove in opening66 a of the front housing member 66, while another O-ring 70 is providedin an annular groove in opening 68 a of rear housing member 68, asillustrated in FIG. 18B. A fitting member 72 is received in front member66 in a recessed pocket 66 e to a threaded opening 66 f extending tochamber 66 b, such that a port 74 is provided having a bore 75 tochamber 66 b. Fitting member 72 is threaded along its surface 72 a toenable the fitting member to screw into threaded opening 66 f of fronthousing member 66. Except for O-rings 70 and 71, the components ofvacuum connection assembly 64 may be made of stainless steel.

The vacuum connection assembly 64 is placed on rigid tube 52 so that thetube extends through openings 66 a and 68 a, O-rings 70 and 71, andchamber 66 b, and an opening 52 c in the rigid tube lies in chamber 66 band faces bore 75 of the fitting member. The diameter of apertures 66 aand 68 b are slightly larger than the outer diameter of rigid tube 52about opening 52 c. O-rings 70 and 71 engage the outer surface of rigidtube 52 to seal chamber 66 b, but for bore 75 and opening 52 c to suturetrack 53 c (FIG. 18C). Flange 68 b from rear housing member 68 isreceived in a pocket 37 (FIG. 9) formed when the left and right sides ofhousing 30 are mated to each other. A vacuum source may be applied viatubing (not shown) to port 74, such that negative air pressure isprovided in chamber 66 b which may be communicated via an opening 52 cof rigid tube 52 along a suture channel formed by suture track 53 c ofguide member 53 to suture track 58 d of guide member 58 through track 56b of coupler member 56, down to the tissue engaging end 16 a. Vacuumconnection assembly 64 may alternatively be coupled at port 74 to asource for air to provide positive air pressure along the same suturechannel, i.e., to drive air down to the tissue engaging end 16 a.

A valve 19 is provided at the bottom of handle 30 a, as shown in FIGS. 9and 10, having a valve seat 19 a and a valve controller 19 b, shown asseparate components in FIGS. 19A and 19B. Valve seat 19 a is composed ofmedical grade rubber, such as Santoprene®, and has a hole 76 extendinginto an interior chamber 78. One side 79 of this chamber 78 has a lip 80about an opening 81. Protruding into the chamber 78 facing opening 81 isa raised member 82 of the valve seat 19 a through which the hole 76extends to an opening 84, which is recessed near a surface 82 a of theraised member 82. The recess of opening 84 forms the shape of an eyehaving two opposing comers 86 when valve 19 is open. Two opposingfingers 88 of the raised member 82 extend from the top and bottom of theeye of opening 84. A valve controller 19 b composed of molded plastic,or other rigid material, has a circular section 90 having an opening 92to an interior surface forming a cam 94, and a recessed retainer ring95. Circular section 90 is received through opening 81 such thatretainer ring 90 is captured by lip 80 to retain valve controller 19 bin valve seat 19 a. Fingers 88 and comers 86 of the raised member 82 ofthe valve seat lie against the surface of cam 94 of the valve controller19 b. The cam surface is wider along one dimension and narrower along aperpendicular dimension, such that when the fingers 88 lie along thenarrower dimension, they compress the recess of opening 84 into a closetslit to close valve 19, and when fingers 88 lie along the widerdimension, the recess of opening 84 returns to its normal shape and thevalve 19 is open. Adjusting the dimensions of the cam surface 94 acontrols the amount of pressure applied to compress opening 84, and thusthe integrity of the closed valve's seal. Another hole 76 b (FIG. 9)extends through opening 92 to the bottom 96 a of turn knob 96 of thevalve controller. The suture routing tube 47 is received in hole 76 ofvalve seat 19 a, as shown in FIG. 9, such that suture material from thetube can pass through openings 76 and 84 of the valve seat and thenthrough hole 76 b of the valve controller.

As shown in FIG. 20A, the valve 19 is open when the finger 88 alignalong surface 94 a and 94 b of the cam 94, and corners 86 are eachreceived in corresponding detents 94 c and 94 d of cam 94. To closevalve 19, a turn knob 96 of the valve controller 19 b is rotated asshown in FIG. 20B. This starts compressing fingers 88 against thesurface of the cam 94 until the fingers 88 lie in detents 94 c and 94 dcompressing opening 84 of the valve seat to close the valve, as shown inFIG. 20C. To open the valve 19, the turn knob 96 is again rotated untilthe corners 86 lie in detents 94 c and 94 d. The turn knob 96 may berotated clockwise or counterclockwise to open and close valve 19. Valve19 may be closed to seal the suture tube 47 when suction is applied viavacuum connection assembly 64, but allows suture to be drawn underslight tension through the valve.

Other types of valve 19 may alternatively be used, such as shown in FIG.19D, which provides a seal, but enables the suture to be drawn underslight tension through the valve. In FIG. 19C, the bottom of handle 30 ais shown in which the suture tube 47 is received in a duck-bill valve128 providing a chamber 128 a and two flaps 128 b extending into thechamber along the length of suture 105 which extends through suture tube47 between flaps 128 b and through an opening 129 in housing 30. Inresponse to negative air pressure in suture tube 47, the two flaps 128 bmeet along edges 128 c providing a seal about the suture 105 in chamber128 a. FIG. 19C illustrates the valve when closed, when open flaps 128 bat edges 128 c may separate from each other.

Referring to FIGS. 21, 21A and 21B, the tissue engaging end 16 a of thesuturing instrument 16 is shown having the sew tip 98 which is mountedin a tip tube 102, such that the front section 98 a of the sew tipextends from tube 102. The mounting of the tip tube 102 to the sew tip98 may be achieved by mechanical fastening by forming small dents in themetal of the tip tube 102 with a press into recessed four pockets 98 b,i.e., two on each side of the sew tip (FIG. 17A). The sew tip 98 has agap 104 in a C-shaped jaw having two openings 98 c at one side of thegap through which each of needles 34 and 35 may extend to captureferrules 103 having one end of suture material 105 located in openings107 at the other side of gap 104, and after each needle captures aferrule, the needle retracts back into their respective opening 98 ccarrying the suture material on its tip. A channel 98 d is provided inthe sew tip which aligns with suture track 58 c of guide member 58, asshown in FIG. 17B. The channel 98 d extends along the length of the sewtip and then fork into two channels, each leading to one of the twoopenings 107 having ferrules 103 to which the end of the suture threadis attached. Openings 107 retain ferrules 103 but are slotted to enablerelease of suture after a ferrule 103 is captured. The operation of sewtip 98 will be described in more detail below in connection with FIGS.22A-22I.

A vacuum sleeve 106 is provided having a tube 106 a, and a rounded cap106 b which closes one end of tube 106. The cap 106 b has an edge 106 cwhich mates with the edge 106 d of tube 106 a and two extending flanges110 which are received in tube 106 a to hold the cap in place (FIGS. 21Cand 21D). Between flanges 110 the interior surface of the cap is angledto provide a ramp 112 (FIG. 21B). The sew tip 98 in tip tube 102 isreceived through the open end 106 f of tube 106 b, such that an opening108 of tube 106 b is located over gap 104 of the sew tip. The twoflanges 110 of cap 106 d register with the two sides of the forward part98 g of the sew tip 98 to properly align sew tip 98 and tip tube 102 inthe vacuum sleeve 106. The opening 108 represents a cut into tube 106 ato provide a oval shaped window 108 a and a forward slot 108 b whichextend from window 108 a to the end of tube 106 a meeting cap 106 b,such that the forward (ferrule carrying) part 98 g of the sew tip 98partially extends through slot 108 b (FIG. 21B). Cap 106 b has a notch106 e located adjacent slot 108 b at edge 106 d of tube 106 a (FIG.21D). The ramp 112 is negatively sloped at an angle towards slot 108 b,as shown in FIG. 21B, to facilitate the suturing process, as will bedescribed later. Two fingers or prongs 103 extend from the sides of thetip tube 102 and are received in two corresponding openings 111 of thevacuum sleeve 106 to latch the sleeve in position over the sew tip.Guide member 58 extends into tip tube 102 as shown in FIG. 18B 21B.Shrink wrap or tubing 114 is then applied over tube 106 a, such thatopenings 111 are sealed closed, to complete the assembly of the vacuumsleeve 106, as shown in FIG. 21A. A short metal ring 116 is placed overthe end 102 a of the tip tube 102 and the edge of the shrink wrap 62extending along shaft 18 b. In placing ring 116, shrink wrap 62 is firstapplied over shaft 18 b and tube 102, and then cut back to an edge 106 aof ring 116. Tubes 102 and 106 a are both made of metal, such asstainless steel, and cap 106 a may be made of molded plastic. Across-section of tissue engaging end 16 a through the sew tip 98, tiptube 102, and vacuum sleeve 106, is shown in FIG. 17. This vacuum sleeve106 enables a vacuum or partial vacuum to be applied to the path of thesuture following gasket member 51, via the vacuum connection assembly64, to channel 98 d of the sew tip 98, such that the upflow of air intothe gap 104 of the sew tip through opening 108 of vacuum sleeve 106 canpull the tissue into the gap. The suction from the vacuum or partialvacuum is applied to gap 104 of the sew tip 98 via two openings 98 e inchannel 98 d to two cavities 98 f each located on opposite sides of thesew tip in the space between the sides of sew tip 98 and vacuum sleeve106 near gap 104 (FIG. 21). Although cap 106 b as described herein ispreferred, cap 106 b may be provided by a metal cap 118, such as ofstainless steel attached to the end of tube 106 a, and provides a smallramp 118 a.

The tissue engaging end of suturing instrument 16 may be as described inU.S. patent application Ser. No. 09/686,420, filed Oct. 11, 2000, whichis herein incorporated by reference. This Patent Application describesthe loading of a length of suture material, i.e., thread, whose ends areaffixed to ferrules in the sew tip 98. Before such loading, the vacuumsleeve 106 is removed from tube tip 102 by pushing in fingers 103 torelease them from openings 111 and then simultaneously pulling thevacuum sleeve 106 away from tube tip 102. After loading, the vacuumsleeve 106 is replaced and latched back (i.e., fingers 103 in openings111) onto the tube tip 102 and the loop of suture extends from theferrules through the suture tracks 53 a and 58 a of guide members 53 and58 to suture routing tube 47, via track 56 b of the coupler member 56and opening 51 a of the gasket member 51, out holes 76 and 76 a of valve19. Proper orientation of the vacuum sleeve 106 over tube tip 102 andsew tip 98 is provided by flanges 111 of cap 106 b, as describedearlier, and also by ramp 112 being angled such that it prevents upsidedown misalignment of the vacuum sleeve over the sew tip. The forwardsection 98 g of the sew tip will be stopped by ramp 112 before fingers103 reach to the tube tip openings 111, preventing the vacuum sleeve 106from latching. For example, the suture material may representmonofilament suture material or braided suture material.

Referring to FIGS. 22A-22I, the operation of the suturing instrument 16at the tissue engaging end 16 a is shown after the suturing instrumentis located, via accessory tube 12, near the tissue to be sutured. FIGS.22A-22H show the process of applying one end of the suture throughtissue 120 with needle 34, the same process is repeated for the otherend of the suture for needle 35. Suturing with needles 34 and 35 may beprovided in any order. In FIG. 22A, the tissue engaging end 16 a isshown with suture material 105 loaded in the sew tip 98, such that thetwo free ends of the loop of suture extend from the suture track 58 a oftube guide 58, via a passage 98 d of the sew tip 98, to two ferrules 103coupled to the two suture ends in the sew tip 98. Opening 98 c at oneend of gap 104 face ferrules 103 in openings 107 for respectivelyneedles 34 and 35. The tissue engaging end 16 a is placed adjacent afirst target area 121 in tissue 120 where the first end of the suturewill be placed (FIG. 22B). Suction is then applied to pull the targetarea 121 of tissue 120 via gap 104 of the sew tip through opening 108 inthe vacuum sleeve 106 to capture a fold 124 of tissue 120 at target area121 (FIG. 22C). To apply suction, valve 19 is closed and a vacuumsource, such as a vacuum pump 200 (FIG. 29B), provides suction to shaft16 b, via tubing, to port 74 of the vacuum connection assembly 64. Thevacuum is communicated into gap 104 via opening 52 c of rigid tube 52 tothe suction channel in shaft 16 b formed by suture track 53 c of guidemember 53, track 56 b of coupler member 56, and then suture track 58 dthrough coupler member 56 to channel 98 d and cavities 98f of the sewtip 98. Principally, the suction is applied to cavities 98 f, howeverthe suction may occur elsewhere about gap 104, such as the space betweenthe sew tip 98 and the interior surface of the vacuum sleeve 106, or viaopenings 107. With the suction maintained, and needle 34 selected by anoperator using selector lever 44, and the actuator member 36 is pulledby the operator towards handle 30 a (FIG. 8), the needle passes throughthe tissue (FIG. 22D) and then into ferrule 103 (FIG. 22E), such thatthe tip 122 of the needle is captured in the ferrule. Although valve 19is closed, the suture may be drawn through the valve seat 19 a. Theactuator member 36 rotates against the bias of spring 38 until needletip 122 engages ferrule 103. The amount of rotation of actuator member36 depends on the distance the needle must transverse before engaging aferrule, such distance may vary depending on the degree of flexing ofshaft 16 b along its flexible section 33. The needle 34 is thenretracted by the operator releasing actuator member 36, to pass theneedle and captured ferrule 103 back through the tissue (FIG. 22F) andinto opening 98 c (FIG. 22G). The suction generates negative airpressure near the tissue 120 sufficient to pull the tissue into gap 104of the sew tip 98 without damaging the tissue. The suction is thendiscontinued, such as by turning off the vacuum source 200, and thevalve 19 opened to release the tissue from gap 104 of the sew tip (FIG.22H). The end of the suture thread extends from the captured ferrule onthe needle tip through tissue 120 to channel 98 d. The suture releasesthrough the slot extending along opening 108 b and the suture extendsfrom captured ferrule through the tissue to channel 98 d. The process ofFIGS. 22A-22H is then repeated at a second target area in the tissuewith needle 35 selected to place the second end of the suture in thetissue. FIG. 22I shows the result after both suture ends are placedthrough tissue, where one suture end extends through tissue fold 124 andthe other through fold 126. For example, the second target area may belocated directly after placing the first suture end through the tissueby rotating the housing 30 of the instrument 180 degree to rotate thetissue engaging end 180 degrees. The entire operation is observed by theoperator via the gastroscope, and in this manner, the first and secondtarget located by the operator in the tissue. The operator may be asurgeon, gastroenterologist, or other skilled physician.

Alternatively, the suturing instrument may operate to apply a suturewithout suction if the target area of tissue can be sufficientlyreceived in gap 104 of the sew tip 98. For example, the target area mayrepresent a raised portion of tissue to be sutured. Further, thesuturing instrument operating without section, may be used with thevacuum sleeve 106 removed from the tissue engaging end 16 a, such asshown for example in FIG. 23.

After two ends of the suture have been placed through the tissue, asillustrated in FIG. 22I, the suturing instrument 16 is removed from theaccessory tube 12, which pulls the loop of suture, which extended fromhousing 30, down to tissue 120. As the suture passes through the tissueengaging end 16 a, the suture follows from channel 98 d of the sew tipover the ramp 112 and notch 106 e of cap 106 b. The suture may then besecure by a suture securing instrument 130 described below.

Referring to FIGS. 24, 24A, and 24B, the suture securing instrument 130of the system is shown having a housing 132 similar to housing 30 ofsuturing instrument 16. Suture securing instrument 130 represents theTi-KNOT® TK•5™ manufactured by LaserSurge, Inc. of Rochester, N.Y.,except that its shaft 134 is longer and partially flexible, and meansare provided for calibrating the length of a drive wire to the distalend 136 of the instrument 130. The distal end of instrument 130 may besimilar to that described in U.S. Pat. Nos. 5,669,917, 5,643,289,5,520,702, or European Patent Application No. 95102587.3, filed Feb. 23,1995 and published Feb. 2, 1994 under Publication No. 0669103A1, whichare herein incorporated by reference. The suture securing instrument 130includes an actuator member 138 representing a lever having two pins 138a extending into holes in the sides of housing 132 upon which theactuator member is pivotally mounted in the housing. Actuator member 138has a portion which extends through an opening 132 a in housing 132 toenable pivotal movement about pin 138 a. A extension spring 140 isprovided which hooks at one end in a notch 138 b of actuator member 138and is wound at the other end around a pin 141 located in holes in thesides of housing 132, such that the actuator member 138 is spring biasedto retain actuator member 138 normally in a forward position, as shownfor example in FIG. 24A. The body of housing 132 has a front portion 132b providing a stop that limits the pivotal movement of the actuatormember 138. A pivot barrel 142 is coupled by a pin 144 which extendsthrough an opening 142 a through the pivot barrel and two holes 143between flanges 144 of actuator member 138. A turnbuckle 146 is providedrepresenting a tubular member which has an interior surface right-handthreaded from one end and left-hand threaded from the other end. Theturnbuckle 146 is attached to a threaded circular end 142 b of pivotbarrel 142 and then to the threaded circular end 148 a of a ballconnector 148. The ball connector has a ball 148 b having a hole 148 cthere through. Drive tube 150 has one end 150 a into which ball 148 b isreceived and then coupled to the tube, via a pin 149, which extendthrough hole 148 c of the ball 148 b and two holes 150 c in drive tube150. An adapter 152 is received in the other end 150 b of the drivertube 150 and has a hole partially extending there through in which isreceived and attached a drive wire 154. The adapter 152 is mounted indriver tube 150 for rotational movement about an annular groove 152 a ofthe adapter 152. Multiple detents (not shown) are formed in the tube150, such as by deforming the metal by pressure, over the annular groove152 a. The detents extend into the annular groove 152 a to form a trackguide within which the adapter 152 may be rotated.

Another adapter 156 is provided which has flanges 156 a received in thetwo sides of housing 132. A rigid tube 158 having an end 158 a which isD-shaped is registered into a corresponding shaped opening in adapter156, and a threaded nut 160 having an opening which extends overmounting tube 158 and screws onto the end of the adapter 156 to securetube 158 to adapter 156. Rigid tube 158 extends from housing 132 via anopening 130 d in the housing. The assembly of components 142, 146, 148,150, 152, and 154 described above are received in the adapter 156 andthrough rigid tube 158, as shown in FIG. 24A. A cross-section of theadapter 156 and rigid tube 158 at pin 149 is shown in FIG. 24C.Cross-section of shaft 134 through the rigid tube 158 at the drive tubeis shown in FIG. 24D, and at the adapter 152 in FIG. 24E. The drive tube150 is moveable through rigid tube 158. At the other end 158 b of therigid tube 158 is another adapter 162 which is cylindrical and has acentral hole 162 a extending there through. The adapter 162 is mountedin tube 158 by mechanical fastening in which small dents in the metal ofthe tip tube formed with a press into two slots 162 b on either side ofthe adapter 162. The drive wire 154 extends through hole 162 a of theadapter 162 and into an extension tube 164 which extends from theadapter 162 to the distal end 136 of instrument 130. Extension tube 164is a stainless steel tube having for example, an inner diameter of 0.041inches and an outer diameter of 0.059 inches, and is mounted in hole 162a of adapter 162, such as by welding or brazing, while enabling movementof the drive wire through adapter 162 and extension tube 164. Drive wire154 may be, for example, stainless steel music wire. A cross-section ofshaft 134 b through extension tube 164 is shown in FIG. 24F. Pivotbarrel 142, turnbuckle 146, ball connector 148, drive tube 150, adapter152, rigid tube 158, and adapter 162 may be made of metal, such asstainless steel, while adapter 156 may be made of molded plastic.

The assembly of the distal end 136 is best shown in FIGS. 25, 25A, and25B. A tip tube 166 is provided having an end 166 a into which isinserted a couple member 168 having an edge 168 a which mates along theedge 166 b of tip tube 166. The end 164 a of extension tube 164 isreceived into a central hole 168 b through coupler member 168 in whichthe drive wire 154 extends through the coupler member 168 and isreceived and attached in opening 171 (FIG. 25C) in a wedge tip section170, where it is attached thereto, such as by welding or brazing. Thewedge tip section 170 has a slot 170 a partially there through intowhich is received the hammer and anvil section 172, such that the hammerand anvil section is slidable in slot 170 a. Sections 170 and 172 arereceived in the tip tube 166. A pin 176 extends through two holes 166 dand an opening 172 a through hammer and anvil section 172 to retainsection 172 in tube 166.

A chamber 173 is provided in the hammer and anvil section into which asecuring sleeve member 174 (FIG. 25B) is located. The securing sleevemember 174 may be a Titanium Knot™ titanium tube manufactured byLaserSurge, Inc. of Rochester, N.Y. Cross-sections through the distalend 136 of the suture securing instrument are shown in FIGS. 24G and25C. The wedge tip section has an upper member 170 b and a lower member170 d having a knife 170 d when wedge tip section 170 is driven forwardupper member 170 b abuts ramp 172 d of the hamper and anvil section 172to first push hammer 172 b down to deform and crimp sleeve member 174against anvil 172 c, and then knife 170 d cut sutures extending fromsleeve member 174 near opening 166 e of tip tube 166. Thus, with ends ofsuture extending through the sleeve member 174 and exit the opening 166e of the tube tip 166, wedge tip section 170 and the hammer and anvilsection 172 provides for crimping the sleeve member to retain the sutureand then cuts the suture in response to forward movement of the drivetube 150 and drive wire 154. Drive tube 150 and drive wire 154 are movedforward by an operator pulling actuator member 138 towards handle 132 cof housing 132, as will be described in more detail in connection withFIG. 27A-H. Rotation of adapter 152 in tube 150 facilitates freedom ofwedge tip 170 to translate, or tilt, along its center axis, whichextends in the direction of wire 154, as the wedge tip is driven forwardagainst the ramped surface of hammer 172 b. Rotational movement ofactuator member 138 is enabled by pivoting of the pivot barrel 142 aboutthe axis defined by pin 144 in flanges 145.

Before attachment of the distal end 136 to extension tube 164 throughwhich drive wire 154 extends, tube 164 is passes through a flexibleplastic tubing 178, such as of Tygon. This tubing 178 extends from end158 b of rigid tube 158, until distal end 136 when mounted to extensiontube 164. The diameter of tubing 178 is substantially matched to theoutside diameter of tube 158 and tip tube 166. A shrink wrap layer 180is applied on the entire length of shaft 134 of instrument 130 untildistal end 136.

The entire length of the instrument 130 is such that it can extendthrough accessory tube 12 in which its shaft 134 has a non-flexiblesection 134 a defined by the extend of rigid tube 158, and a flexiblesection defined by the extent of extension tube 164 in tubing 178. Forexample, the shaft 134 may be 31.5 inches in length, where itsnon-flexible section 134 a is 12.0 inches in length, and the flexiblesection 134 b is 19.5 inches in length.

Referring to FIGS. 26A-26D, the loading of sleeve member 174 into thedistal end 136 of the suture securing instrument 130 is shown using aflexible holder 182 having a outer groove (not shown) around which awire 184 is passed to forming a loop. This loading holder iscommercially available as a Ti-KNOT® TK•5™ Quick Load™ unit fromLaserSurge, Inc., Rochester, N.Y. Holder 182 may be made of moldedrubber, and having an opening 182 a for the fingers of an operator. Theends of the wire loop 184 are attached to a C-shaped or curved handle186, which may be composed of metal. A sleeve member 174 is slid alongring 186 until reaches the end of the ring at 186 a (FIG. 26A). The ring186 is then passed through chamber 173 of the distal end 136 between thehammer 172 b and anvil 172 c of section 172 and then exits throughopening 166 e of the tip tube 166 (FIG. 26B), until sleeve member 174 islocated in chamber 173 (FIG. 26C). The flexible holder 184 may then beremoved (FIG. 26D).

Referring to FIGS. 26E-26I, the loading of the two ends of a loop ofsuture 105 through a loaded sleeve member 174 in the distal end 136 ofthe suture securing instrument 130 is shown. The two ends of suture 105are passed through the wire loop 184 (FIG. 26E), as shown by arrow 188,and are captured by the wire loop as the C-shaped handle 186 is used topull the wire loop through the sleeve member 174 (FIG. 26F) and opening166 e of the tube tip 166, thereby pulling the two ends of the loop ofsuture through the sleeve member and opening 166e in the directionindicated by arrows 190-192 (FIGS. 26G-26I).

FIGS. 27A-27H shows the operation of suture securing instrument 130 tosecure and cut the suture. With the ends of the loop of suture 105extending through the sleeve member 174 at the distal end 136 of thesuture securing instrument 130, the instrument maybe inserted into theaccessory tube 12 down to the tissue through which the suture loopextends. The ends of the suture are pulled through the distal end 136,until sleeve member 174 is located adjacent the tissue (FIG. 27A). Anoperator then pulls the actuator member 138 towards handle 132 c,driving forward the wedge tip section 170 in which the motion istranslated through shaft 134 via pivot barrel 142, turnbuckle 146, ballconnection 148, through drive tube 150 and drive wire 154. In response,the upper member 170 b of the wedge tip section 170 slides forwardagainst hammer 172 b deforming the sleeve member against anvil 170 c toretain the suture. FIGS. 27B-27E illustrates the downwards movement ofthe hammer deforming on the sleeve member as the wedge tip section 170is driven forward. The knife 170 d at the lower member 170 c of thewedge tip section 170 is also driven forward against the suture (FIG.27F), to cut the ends of the suture near the sleeve member 174 (FIG.27G). The operator then releases the actuator member 138 whichautomatically retracts in response to the forward bias by spring 140,and the wedge tip section 170 retracts releasing the sleeve member 174from between hammer 172 b and anvil 172 c (FIG. 27H). The distal end 136of suture instrument 130 is then removed leaving the crimped sleevemember 174 a to retain the sutured tissue closed (FIG. 27I).

Referring to FIGS. 28A-28M and 29A-29F the overall operation of system10 will now be described in which FIGS. 28A-28M illustrate examples ofthe images on a display 193 provided by the gastroscope 14, and FIGS.29A-29F illustrate the relative position of the gastroscope 14,accessory tube 12, and instruments 16 and 130 during suturing and suturesecuring. With the patient 194 ready for the procedure, the gastroscope14 and attached accessory tube 12 are inserted through the mouth 195down the esophagus 196 and into the stomach 198 where the suturing willtake place (FIG. 29A). The suturing instrument 16 with a loop of suture105 loaded is then inserted into the accessory tube 12 via cannula 20,until the distal end 16 a passes through attachment tip 26 (FIGS. 28Aand 29A). The tissue engaging end 16 a of the suturing instrument 16 isviewable to the operator on display 193 through the gastroscope (FIG.28A). With the target area of the tissue located, the valve 19 isclosed, and suction is applied to instrument via a vacuum source 200 andcontrol (or regulator) 202 via tubing 201 to pull the tissue into gap104 of sew tip 98, as described earlier (FIG. 28B). Control 202 may beintegrated in vacuum source 200 or along tubing 201, and is used toselectably enable and disable suction to the sew tip 98 in vacuum sleeve106. A first one of needles 34 or 35 is then extended and retracted bythe operator, as described earlier, to locate the first end of thesuture in the tissue. The suction is then disabled, valve 19 opened, andthe sew tip is lifted leaving the suture extending through the tissue(FIGS. 28C, 28D, 28E, and 28F). The target area for the second end ofthe suture is then located, valve 19 closed, and vacuum again enabled topull the tissue into the sew tip 98 (FIG. 28F). A second one of theneedles 34 or 35 is extended and retracted to locate the second end ofthe suture in the tissue. The suction is then disabled, valve 19 opened,and the sew tip lifted leaving the suture extending through the tissue.FIG. 28G shows an image of the first and second ends of the suture inthe tissue. The suturing instrument 16 is then removed from theaccessory tube as shown in FIG. 29C, pulling a loop 105 a of suture 105through the stomach tissue (FIGS. 28H-28J). The ends of the suturematerial are cut from the suturing instrument 16 and then loaded throughthe suture securing instrument 130 which has been loaded with a sleevemember 174, as shown in FIG. 29D. The suture securing instrument 130 isthen inserted into the accessory tube 12 while gentle tension is appliedto the free ends of the loop of suture (FIG. 28K). The distal end 136 ofthe suture securing instrument passes through the attachment tip 26 andis located near the suture loop extending from the tissue (FIG. 28L).The suture securing instrument 130 is positioned adjacent to the tissue,appropriate suture tension applied and the instrument is then actuatedas described earlier to crimp and cut the sleeve member (FIG. 28M), andthen the instrument 130 is removed leaving the crimped sleeve member 174a to close the suture (FIG. 28N). FIG. 29F illustrates the patient afterthe suture is closed and the suture securing instrument is removed. Thegastroscope 14 and attached accessory tube 12 remains in the patientduring both the suturing and suture securing operations, and thisprocedure does not require the use of an overtube. If additionalsuturing is required, the suturing instrument 16 may be reloaded withanother suture loop and above described procedure repeated with thesuture securing instrument reloaded with another sleeve member to securethe suture closed. In this manner, multiple sutures may be made in thestomach tissue with a single insertion of the gastroscope 14. Whensuturing is completed, the gastroscope 14 and attached accessory tube 12are removed from the patient.

Although the suturing instrument 16 and suture securing instrument 130are described for use with gastroscope 14, instruments 16 and 130 may beused separately from the gastroscope 14 and accessory tube 12. Further,suturing instrument 16 and suture securing instrument 130 may passthrough an internal channel 28 d (FIG. 1B), often called a working orbiopsy channel, provided in gastroscope 14 to its distal end 14 a sizedto receive the respective shaft of the instrument.

Referring to FIGS. 30-35, another embodiment of the suturing instrument16 is shown to provide additional flexibility within section 33 of shaft16 b of the instrument. This additional flexibility facilitate furtherfreedom for section 33 to flex in the accessory tube 12 with the flexingof gastroscope shaft 14 a in positioning the distal end 14 b of thegastroscope. Suturing instrument 16 is the same in this embodimentexcept for the components in section 33 between coupler member 56 andsew tip 98. Needles 34 and 35 in this embodiment are illustrated in FIG.31 as needle assembly 203. For illustration purposes, needle assembly203 for needle 34 is shown, since needles 34 and 35 are identical. Aneedle driver 204 is coupled to ball 34 a by welding or braising into ahole in the ball. Needle driver 204 is a stainless steel wire or tube. Acable 206 is received in a hole 205 in one end 204 a of needle driver204. A spring 207 is installed at one end 207 a over the cable 206 andattached, such as welded or crimped, to end 204 a of the needle driver204. The other end of cable 206 is received in a hole 209 at end 208 aof needle 208, and the end 207 b of spring 207 is attached such aswelded or crimped, to end 208 a of the needle. Cable 206 is a stainlesssteel wire or braided cable. Spring 207 is a stainless steel extensionspring which is normally compressed, and has an inner diameter slightlylarger than the outer diameter of cable 206. For example, inner diameterof spring 207 may be 0.020 inches, and the outer diameter of cable 206may be 0.018 inches. The outside diameter of spring 207 may be matchedto the outside diameters of needle driver 204 and needle 208. The lengthof needle driver 204, needle 208, and cable 206 in spring 207, is suchthat the tip 122 of the needle 208 lies in the sew tip 98 when theneedle is fully retracted.

Needle assembly 203 for each of needles 34 and 35 extends through amulti-lumen tube 210 which is attached at end 210 a to coupler member 36by tabs 56 f being received in corresponding pockets 212 at end 210 a,and is attached to sew tip 98 by tabs 100 of sew tip 98 in pocket 214 atend 210 b. For purposes of illustration, needles are not shown in FIG.32. Multi-lumen tube 210 is made of flexible material, such as plastic,polyurethane, or pebex, and has two holes 216 through which needles 34and 35, respectively, each extend, as best shown in FIG. 32A, where thespring 207 and needle 205 are shown through holes 216. The holes 216have a diameter slightly larger than the outside diameter of the spring207. The tube 210 is longitudinally reinforced, such that it cannot besubstantially stretched or elongated. Such longitudinally reinforcementof the tube may be provided by a stainless steel kevlar, or nylon weaveinstalled in the tube when it is extruded, or the weave may beadhesively bonded to the outer surface of tube 210. A suture hole 218extends through tube 210 for passage of suture, and negative or positiveair pressure, similar to hole 58 d of guide member 58. End 204 a ofneedle driver 204 and end 208 a of needle 208 are located in tube 210for each needle in holes 216. Attachment of tip tube 102, ring 116, andsew tip 98 is the same as described earlier.

The operation of suturing instrument 16 in this embodiment is the sameas described earlier, except that when actuator member 36 of instrument16 is pulled by an operator for needle 34 or 35, forward movement istranslated to needle 208 via needle driver 204 and spring 207, whichcompresses to assist in pushing forward needle 208 in sew tip 98. Whenactuator member 36 is retracted, the cable 206 and spring 207 assist inpulling needle 208 back.

Alternatively in this embodiment, the multi-lumen tube 210 may bereplaced by needle carrying tubes 220 and suture supply tube 222. Theneedle assembly 203 for each of needles 34 and 35 extends through tubes220, respectively, as shown in FIGS. 33 and 34, while the suture supplytube 222 provides a path for suture to sew tip 98, and also can providenegative (or positive) air pressure, as described earlier via vacuumconnection assembly 64. Supply tube 222 extends from chamber 66 b ofvacuum connection assembly 64 through hole 53 c of guide member 53,through suture track 56 b of coupler member 56, and then along flexibleshaft section 35 to sew tip 98. Tubes 220 and 222 may be made offlexible stainless steel tubing or reinforced plastic, pebex, orpolyurethane tubing, or nickel titanium tubing, such as nitnol. FIG. 35shows needle assembly 203 at one end of tubing 220. In this embodiment,shrink wrap 62 (FIG. 10) covers multi-lumen tube 210, or tubes 220 and222 if no multi-lumen tube is used, such as described earlier for guidemember 58. Optionally, to enhance needle carrying tubes 220 flexibility,the tubes 220 may each represent a wound spring 234 with outer sheath236, such heat shrink tubing, on the outside surface of the spring 234,as shown in FIGS. 35A and 35B. The interior diameter of the spring 234is slightly greater than the outside diameter of needle assembly 203extending there through. The outer sheath 236 is shrunk to the springonly at the ends 234 a and 234 b of the spring 234, such that elongationof spring 234 is restricted. The interior diameter of outer sheath 236is larger than outside diameter of spring 234 to allow flexure of spring234.

Referring to FIGS. 36 and 36A, a further embodiment of suturinginstrument 16 is shown in which suction to the sew tip is providedwithout vacuum connection assembly 64. In this further embodiment, boththe vacuum connection assembly 64 and opening 52 c to rigid tube 52 isremoved, and an opening 224 is provided through the shrink wrap 62 tosuture track 58 c of guide member 58. An additional ring seal 227 (FIG.36A) is provided in the opening 26 b extending through attachment tip26. Ring seal 227 is composed of the same material as attachment tip 26,and represents a ring extending from the interior surface of the opening26 b having a diameter slightly smaller than the largest diameter oftissue engaging end 16 a. The tissue engaging end 16 a can pass throughthe seal 227, while ring seal 227 engages the outer diameter of thetissue engaging end. Suction may then be applied via cannula port 20 e(FIG. 6) of the accessory tube 12 and communicated through opening 224to the suture channel, i.e., suture track 58 c and channel 98 d tocavities 98 f gap 104 of the sew tip 98, as described earlier, wheninstrument 16 is located through accessory tube 12. This suction may beprovided from vacuum source 200 (FIG. 29B) through controller unit 202and tubing 201 to port 20 e, rather than to the vacuum connectionassembly 64.

Referring to FIGS. 37-39, system 10 may optionally have positionallocking of tissue engaging end 16 a to lock the rotational position andto limit forward longitudinal travel of the tissue engaging end 16 a ofthe suturing instrument in attachment tip 26 of the accessory tube 12.Such locking is provided by adding one or more protrusion members 226 toring 116 of tissue engaging end 16 a. For example, ring 116 may have twoprotrusion members located 180° apart along the outer circumference ofring 116. These protrusion members 226 may be made of stainless steel ormolded from plastic, and attached, such as adhesively bonded, or ifmedal by welding or brazing, to the outer surface of ring 116.Protrusion members 226 are shaped to be received by slots 228 in opening26 b extending through attachment tip 26. For example, eight slots 228are provided at 30 degree increments about the interior surface ofopening 26 b, such that two protrusion members 226 may be received inone of four opposing (180° apart) pairs of slots 228. Lesser or greaternumbers of slots may also be provided. Each slot 228 extends from end230 of attachment tip 26 partially into opening 26 b to provide a stop231. The height of the protrusion member 226 from the outer surface ofring 116 is slightly less than the depth of the slots 228, and width ofthe protrusion members 226 is slightly less than the width of slots 228,such that protrusion members 226 can easily engage with an opposing pairof slots 228. Protrusion members 226 each have a forward round-shapedend 226 a that facilitates the alignment of the protrusion members 226in slots 228 to limit instrument 16 rotation and forward travel.

In operation, when the tissue engaging end 16 a of the instrument 16passes through accessory tube 12 and through the attachment tip 26, thedistal end 14 a of the gastroscope 14 can view the vacuum sleeve, andpartially the sew tip therein, prior to engagement of protrusion members226 in a pair of opposing slots 228. The operator then can preciselylocate the position of gap 104 of the sew tip with respect to a tissuetarget area 121 (FIG. 22B), as described earlier. With the target arealocated and sew tip gap 104 aligned to face the target area, andsubstantially parallel thereto, the operator slightly rotates theinstrument at housing 30, such by handle 30 a, and pushes the instrumentto locate and engage the protrusion member 226 of ring 116 of the tissueengaging end 16 a in the closest pair of opposing slots 228 in opening26 b of the attachment tip 26 which corresponds to the desired alignedrotational position of the sew tip's gap 104 with respect to the tissuetarget area, until protrusion members' end 226 a abut stop 231. Once thetissue engaging end 16 a is so rotationally locked in position, the riskof rotational misalignment of the sew tip gap 104 when tissue iscaptured therein is reduced. To select another target area 126 (FIG.22F), the operator rotationally unlocks tissue engaging end 16 a bypulling the instrument handle 30 slightly back which disengages theprotrusion members 226 from slots 228.

Referring to FIGS. 40, 40A, 41, 42, and 42A, optionally the suturinginstrument 16 may have a steering mechanism for flexing needle engagingend 16 a. This steering mechanism includes a control cylinder 238 havingwalls defining an interior chamber 240 having therein a plunger orpiston 242 attached to the end of a threaded shaft 244 a, which is heldin the chamber 240 by a threaded nut 246 (FIG. 40A). The threaded nut246 is attached to the chamber 240 by insert molding. A thumb wheel 248attached to the turn screw 244 enabled the shaft 244 a of the turn-screwto rotate along threaded nut 246 and control the position of the piston242 in chamber 240. Piston 242 has a rubber ring seal 243 which engagesthe interior surface 240 b of chamber 240. An opening or outlet 248 atone wall of chamber 240 provides a flow path for the volume 241 ofliquid 245 contained in the chamber 240, where this volume 241 isdefined by the surface 242 a of the piston 242 facing opening 248 andthe interior surface 240 b of the chamber 240.

As shown in FIG. 40, at least one exterior surface of a wall of controlcylinder 238 is molded into housing 30, or the control cylinder 238 isapplied by adhesive to the outer surface of housing 30. Shaft 244 a andnut 246 may be made of stainless steel, while walls of chamber 240,piston 242 and thumb wheel 248 may be made of plastic, such ABS. Inhousing 30, a flexible tube 250 is coupled at one end to outlet 248 andextends through an opening 252 located in the rigid tube 52 after gasketmember 51 and before vacuum connection assembly 64, and then tune 250follows a path along one of tracks 53 d of guide member 53 in rigid tube52, and through a hole 254 of coupler member 56 extending through itstab 56 a and 56 d (as shown in dashed lines in FIG. 41). From couplermember 56, the tube 250 extends along one of tracks 58 d of guide member58 to a cylinder 256 located in the track 58 d before sew tip 98 (FIG.42). For example, tube 250 may be made of flexible plastic material. Asshown in FIG. 42A, cylinder 256 has walls defining a interior chamber256 a having an opening 256 b in one wall to this chamber which theother end of tube 250 is connected, such as by adhesive bonding. Apiston or plunger 256 c in chamber 256 a is coupled to a rod 258extending through an opening 256 d in a wall of the chamber. The surface256 e of piston 256 c faces opening 256 b and is positionable in chamber256 a to change the volume 257 of liquid 245 contained in the chamber,where volume 257 is defined by surface 256 e of the piston 256 c and theinterior surface 256 f of cylinder 256.

Rod 258 has at its end 258 a a hole 258 b into which a flexure member260 is attached, such as by welding or crimping. Flexure member 260extends into a hole in one end of tabs 100 of sew tip 98, and isattached thereto by welding or crimping. Flexure coupler 260 allows forpossible misalignment between rod 258 and tab 100 of the sew tip 98.Cylinder 256 is fixed in place in one of tracks 58 d, such as byfrictionally engagement when shrink wrap tubing 62 is applied over guidemember 58, or may be bonded by adhesive. For example, the components ofcylinder 256 may be made of stainless steel, except piston 256 c whichmay be made of rubber.

To steer the sew tip, an operator of the suturing instrument 16 turnsthe thumb wheel 248 changing the volume of fluid 245 in chamber 240, andmoving the fluid into or out of outlet 248 and tube 250. In response,the volume of fluid 245 in chamber 256 c of cylinder 256 changes, andpiston 256 c and rod 258 moves in cylinder 238 causing the rod to extendor retract to flex tissue engaging end 16 a, via flexure coupler 260.For purposes of illustration, arrows 239 indicate flexure of the tissueengaging end 16 a of instrument 16. Fluid 245 may be, for example,water. This provide for a hydraulic steering mechanic which an operatorof the instrument 16 can use to provide additional control inpositioning the tissue engaging end during suturing, such positioningbeing independent of other steerability of the tissue engaging as may beprovided by flexure of gastroscope's shaft 14 b.

Alternatively, cylinder 256 may be replaced by a folding piston 262, asshown in FIG. 42B and in more detail in FIG. 42C. Folding piston 262 haswalls defining a cavity 262 a which can longitudinally expand orcontract due to changes in volume 263 of liquid 245 contained in thecavity from movement of the fluid through an opening 262 b in one of thewalls to which tube 250 is connected, such as by adhesive bonding. Rod258 is attached to end 262 d of folding piston 262, by adhesive bondingor is molded to end 262 d. Folding piston 262 may be made of plastic,stainless steel, or of heat shrink tubing.

Folding piston 262 can be manufactured with a process using thin walledtransparent or white heat shrink plastic tube 270 made from anon-elastic plastic, like polyester. FIG. 45A shows dark, lightabsorbing, lines 271 printed directly onto the tube 270 when it iscollapsed flat. FIG. 45B shows the same tube 270 having plugs 273 withopenings 262 b into the tube, and pressurized with a medium (not shown), such as water or air, through conduits to one or both openings 262 b.Water is a preferred pressurized medium, because it also acts as heatsink to ensure localized heating of the tube only at the desired,printed sites. An appropriate fluence of light, such as produced by alaser, for a specific duration to generate heat along such dark lines ofthe tube 270 provides controlled radial and axial shrinkage of the tube(FIG. 45C). Such changes to the tube shape permits longitudinal foldingof tube 270, as indicated by arrow 272 (FIG. 45D). When the intraluminalpressure and volume are decreased and direct outside pressure is appliedto either or both ends of the tube 270, such as via opening 262 b, thetube can collapse in length by folding in near the heat shrunk zones274, and thus provide folding piston 262. By increasing pressure andvolume within folding piston 262, the folded zones 274 will reexpandlongitudinally to re-establish the length of the folding piston 262. Bycontrolling volume and pressure within the folding piston 262, pistonlength is readily altered. Alternatively, light activated thermalmodification of heat shrink tubing can be achieved by using a wellcontrolled circumferential application of focused light, such as laserlight, or by careful masking of the heat shrink tubing, or by placing acompliant marked mandrel or tube within a clear heat shrink tube andexposing to appropriate lighting conditions.

In a further alternative, a wire 263 may replace tube 250, such that amechanical steering mechanism is provided. As shown in FIG. 44, wire 263follows the same path as tube 250, except that a piston in no longerrequired in cylinder 238. Instead, the wire 263 is coupled in cylinder238 to shaft 244 a to a ball 265, which is retained in a socket 267formed at the end of the shaft 244 a. A cap 269 has a hole for wire 263and is received and attached to the socket, such as by welding orbrazing, to retain the ball onto the socket, but enable rotation of theball so that the rotation of the shaft 244 a is not transferred to thewire 264. The wire passes through a tube 266, such as made of stainlesssteel extending between outlet 248 and opening 252 of the rigid tube 52(FIG. 44). Tube 266 is attached to opening 252, such as by welding orbrazing. The wire passes along one of tracks 53 d of guide member 53extending with the guide member through rigid tube 52, and then throughhole 254 of coupler member 56 through its tab 56 a and 56 d, along oneof tracks 58 d of guide member 58 to the sew tip 98 (FIG. 44A). Wire 262is attached to a hole 268 extending into tab 100 of the sew tip 98, suchas by welding or brazing.

From the foregoing description, it will be apparent that there has beenprovided an improved system and method for endoscopic suturing.Variations and modifications in the herein described system and methodin accordance with the invention will undoubtedly suggest themselves tothose skilled in the art. For example, the entire shaft 16 b or 134 ofinstruments 16 or 130, respectively, maybe flexible along their length.Accordingly, the foregoing description should be taken as illustrativeand not in a limiting sense.

1-32. (canceled)
 33. A method for suturing tissue comprising the stepsof: providing an endoscope having a flexible shaft and an accessory tubecoupled externally to said shaft which flexes in accordance with flexingof said shaft; locating an endoscope with said coupled accessory tube inthe body of a patient; and inserting a suturing instrument through saidaccessory tube into the body of the patient to place two ends of a loopof suture through tissue.
 34. The method according to claim 33 whereinsaid inserting step further comprises the steps of: providing a shaftfor said suturing instrument and a distal tissue engaging end coupled tosaid shaft of said suturing instrument having a sew tip with a gap; andapplying suction along said shaft to said gap of said sew tip to enabletissue to be pulled into said gap when each end of said loop of sutureis place in tissue.
 35. An attachment for a flexible endoscope having ashaft extending to a distal end comprising: a flexible tube capable ofbeing coupled externally to said endoscope to be flexible with flexingof said shaft of said endoscope; and said tube having a distal endattached to said shaft of said endoscope.
 36. The attachment accordingto claim 35 wherein said proximal end of said tube has a sealableopening which opens to allow an instrument to pass into said tube andcloses when the instrument is removed from the tube.
 37. The attachmentaccording to claim 35 further comprising: a plurality of guides eachattached at a location along said shaft of said endoscope and having anopening through which said tube extends in which said tube is capable ofsliding through said opening in response to flexing of said shaft ofsaid endoscope.
 38. The attachment according to claim 36 wherein saidsealable opening is provided by a cannula attached to said tube having asealable passage in communication with said tube.
 39. The attachmentaccording to claim 35 wherein said tube represents a conduit enablingenables access of an instrument independent of said endoscope near saiddistal end of the shaft of the endoscope.
 40. A suturing instrumentcomprising: a housing; a shaft extending from said housing; a tissueengaging end coupled to said shaft at the distal end of the instrument;one or more needles which extend through said housing through said shaftto said tissue engaging end; a suture channel extending through saidhousing and said shaft to said tissue engaging end; said tissue engagingend having a sew tip with an opening through which said needles areextendable to each capture one end of suture extending through saidsuture channel to said sew tip; and said shaft having a first sectionand a second section, said first section being rigid and extends fromsaid housing, and said second section being flexible and extends fromthe first section to the tissue engaging end of said suturinginstrument.
 41. The suturing instrument of claim 40 wherein said openingof said sew tip represents a first opening and said suture channelhaving first and second ends in which said first end is adjacent saidsew tip, and said suturing instrument further comprises: a sleeve oversaid sew tip having one end capped and an second opening incommunication with said first opening of said sew tip; means forselectably providing suction to said suture channel along said shaft tosaid first opening of said sew tip to enable tissue to be pulled intosaid first opening through said second opening of said sleeve when saidneedle extends through said opening of said sew tip in which said cappedsleeve enables suction to be communicated to said distal end of theinstrument; and means for selectably closing said second end of saidsuture channel to enable suction to be provided at said sew tip by saidsuction providing means.
 42. The suturing instrument of claim 40 whereinsaid needle comprises first and second members and a spring whichcouples said first and second members, and said second member has a tippositionable in said sew tip.
 43. A suture securing instrumentcomprising: a shaft which is at least partially flexible; a distaltissue end coupled to said shaft; means for retaining in a sleeve memberat said distal end two free ends of a loop of suture extending throughtissue; and means for cutting the two free ends of the loop of suturenear said sleeve member.
 44. (canceled)
 45. The attachment according toclaim 35 further comprising: one or more first members through whichsaid tube is slidable and said first members are attachable at locationsalong said shaft of said endoscope; and a second member attached to saiddistal end of said tube in which said second member is attachable to thedistal end of the shaft of the endoscope, in which said tube operates asa conduit for passage or one or more instruments along outside saidshaft of said endoscope.
 46. An apparatus for use with an endoscopehaving a flexible shaft with a distal end comprising: a flexible tubehaving a distal end; a member attachable to said distal end of the shaftof the endoscope and to said distal end of said tube; and means forenabling the shaft of the endoscope and said tube to slide with respectto each other in response to flexing of said shaft of said endoscope, inwhich said tube operates as a conduit for passage of one or moreinstruments.
 47. The apparatus according to claim 46 wherein said meansmaintains said tube substantially coaxial with the shaft of theendoscope.
 48. A suturing instrument comprising: a shaft; a tissueengaging end coupled to said shaft at the distal end of the instrument;one or more needles which extend through said shaft to said tissueengaging end; means for carrying suture along said shaft to said tissueengaging end; said tissue engaging end having an opening to a cavitythrough which said needles are extendable to each capture one end of thesuture; and means for applying suction along said shaft to said cavityof said tissue engaging end to enable tissue to be pulled into saidopening when said needles are extended, wherein said shaft is not partof an endoscope.
 49. The suturing instrument of claim 48 wherein each ofsaid needles comprises first and second members and a spring whichcouples said first and second members to aid in flexibility of saidneedles.
 50. The suturing instrument of claim 48 wherein: said shaft hasa first section and a second section; said tissue engaging end iscoupled to said second section of said shaft; said one or more needlesextend through said first and second sections of said shaft to saidtissue engaging end; said suture carrying means comprises a suturechannel extending through said first and second sections of said shaftto said tissue engaging end; said first section has an outer tube and afirst guide member extending in said outer tube having a plurality oftracks for said needles and suture; said second section of said shafthas a second guide member having a plurality of tracks for said needlesand suture; and said shaft has an outer layer extending over at leastsaid second guide member to said tissue engaging end, and a couplermember coupling said first guide member to said second guide member toenable rotation to be translated from said first section to said tissueengaging end through said second section.
 51. The suturing instrument ofclaim 48 further comprising means for steering said shaft.
 52. Thesuturing instrument of claim 51 wherein said steering means comprises: achamber at or near the proximal end of said instrument having a fluidand a piston in said chamber movable to change the volume of the fluidin said chamber, an opening to said chamber, and a tube coupled to saidopening extending along said shaft to said distal end; and a cylinderalong said shaft having a piston coupled to said distal end movableresponsive to changes in said volume of fluid in said chambercommunicated through said tube to said cylinder to steer said distalend.
 53. The suturing instrument of claim 51 wherein said steering meanscomprises: a chamber at or near the proximal end of said instrumenthaving a medium and a piston in said chamber movable to change thevolume of said medium in said chamber, an opening in said chamber, and atube coupled to said opening extending along said shaft to said distalend; and a folding piston coupled to said distal end expandable andretractable responsive to changes in said volume of said medium in saidchamber communicated through said tube to said cylinder to steer saiddistal end.